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ZYNRELEF® for Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy

NCT05863221 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-05-18

No results posted yet for this study

Summary

Approximately 120 subjects will be randomized into 1 of the following 2 treatment groups in a 1:1 ratio:

Group 1: ZYNRELEF® up to 200 mg/ 6mg ( 7ml vial) via instillation at all incision sites in addition to 30 ml of 0.5% Ropivacaine + 10mg dexamethasone. Postoperatively, intermittent IV acetaminophen will be administered as per need till discharge.

Group 2: 30 ml of 0.5% Ropivacaine and 10mg dexamethasone into all surgical sites and intermittent IV acetaminophen as per need till discharge.

Primary Objective:

To compare the efficacy and duration of analgesia achieved following the instillation of ZYNRELEF® all incision sites in addition to Ropivacaine with dexamethasone + postoperative IV acetaminophen, to the standard treatment of Ropivacaine with dexamethasone + postoperative IV acetaminophen in subjects undergoing laparoscopic sleeve gastrectomy.

Secondary Objectives:

1. To evaluate additional efficacy parameters, including opioid load, in this study population.
2. To determine the impact of ZYNRELEF® on the cost of pain management.
3. To assess the time taken to resume exercise after discharge.
4. To assess the adverse events reported following the use of ZYNRELEF®.

Conditions

  • Post Operative Pain, Acute
  • Bariatric Surgery Candidate
  • Postoperative Pain

Interventions

DRUG

ZYNRELEF 200Mg-6Mg Extended-Release Solution

ZYNRELEF® is an extended-release, fixed-ratio combination product that contains bupivacaine (a local anesthetic as the free base) and low-dose meloxicam (an NSAID) incorporated in a bioerodible polymer (termed Biochronomer®).

Sponsors & Collaborators

  • Heron Therapeutics

    collaborator INDUSTRY

  • Dr. Yannis Raftopoulos

    lead OTHER

Principal Investigators

  • Yannis Raftopoulos, MD · Holyoke Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-09
Primary Completion
2024-10-09
Completion
2024-10-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05863221 on ClinicalTrials.gov